XBeam (v2)
Xstrahl Ltd.XBeam (v2) is a software tool designed to calculate and validate the radiation dose or monitor units needed during external beam radiation therapy. It supports treatment planning for superficial and orthovoltage radiotherapy systems made by Xstrahl. By accurately calculating treatment parameters like beam-on time and dose, it helps ensure patients receive the prescribed radiation safely and accurately. The software is intended for use by trained medical physics professionals to improve the quality assurance of radiation treatments.
Intended Use
The XBeam Software can be used for validating the monitor units or radiation dose to a point that has been calculated by hand or another treatment planning system for external beam radiation therapy. It can also be used as a primary means of calculating the monitor units or radiation dose to a point for external beam radiation treatments. It is intended for use with Xstrahl’s superficial and orthovoltage radiotherapy and surface electronic brachytherapy systems by authorized personnel trained in medical physics.
Technology
XBeam is a standalone dose calculation software that determines beam-on time or monitor units based on applicator and filter selection for Xstrahl radiotherapy devices. It uses percent dose depth (PDD) curves and absolute dose output data for calculation, supporting single or two parallel opposed beams and allowing treatment parameter calculations for specified devices.
Performance
The device underwent extensive verification and validation testing including 323 verification tests, clinical workflow and usability validation, and dosimetric accuracy assessments. Dose calculations by XBeam closely matched hand calculations and predicate device RADCalc with maximum difference 0.7%. Dose delivery accuracy was within clinically acceptable uncertainty ranges, confirming safety and performance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/11/2024
8 months - 2
FDA Approval
12/4/2024
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